Recall Z-1659-2013 ยท NAV Graft, Bypass, Coronary Artery
The Anspach Effort, Inc.
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpie
| Date | Jul 2, 2013 (initiated Jun 24, 2011) |
| Status | Terminated |
| Reason | The RPM of the Motor Handpiece may be less than 80,000 RPM. |
| Root cause | Process control |
| Action | Anspach Effort sent an "URGENT: Medical Device Correction" letter dated June 24, 2011 to their customers via mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a reply form promptly confirming receipt of their letter and return it by fax to the number provided on the form. If any of the affected products were distributed to other services or facilities, please forward this information as appropriate. For questions contact Anspach Customer Support at 800-327-6887 or email customer.support@synthes.com. |
| Quantity | 61 units |
| Distribution | Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.